Muscle Anabolic Response to β2-adrenergic Stimulation With Increased Amino Acid Availability.

April 7, 2025 updated by: Morten Hostrup, PhD, University of Copenhagen

The Importance of Amino Acid Availability in Modulating the Muscle Anabolic Response to β2-adrenergic Stimulation.

The purpose of the project is to investigate the effect of amino acid availability on the muscle anabolic response to beta2-adrenergic stimulation in young healthy men and women.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • August Krogh Building
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-40
  • Physically active >5 hours a week
  • Maximum oxygen uptake classified as high or very high

Exclusion Criteria:

  • Active smoker currently or within the past 5 years
  • Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
  • Chronic or acute illness deemed by the responsible study physician to affect the test parameters
  • Deviation from the study protocol
  • Lean mass index >21 kg/m²
  • Pregnancy
  • Smoker
  • Blood donation during the past 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Salmeterol + amino acid availability
The participants will be administered salmeterol from an inhaler device and amino acid availability (protein powder in a shaker) daily during a 6-week intervention.
Drug: Salmeterol + amino acid availability
The participants will be administered 200 µg salmeterol (8 puffs) from a MDI device and 40 g amino acid availability (clear whey in a shaker with water) daily during a 6-week intervention. Participants will be instructed to provide documentation of both the inhalation and the shaker intake via video.
Experimental: Salmeterol + placebo
The participants will be administered salmeterol from an inhaler device. Furthermore they will be administered placebo (carbo fuel in a shaker) daily during a 6-week intervention.
Drug: Salmeterol + placebo
The participants will be administered 200 µg salmeterol (8 puffs) from a MDI device. Furthermore they will be administered 80 g placebo (carbo fuel in a shaker with water) daily during a 6-week intervention. Participants will be instructed to provide documentation of both the inhalation and the shaker intake via video.
Placebo Comparator: Placebo + placebo
The participants will be administered placebo from an inhaler device. Furthermore they will be administered placebo (carbo fuel in a shaker) daily during a 6-week intervention.
Drug: Placebo + placebo
The participants will be administered placebo (8 puffs) from a MDI device. Furthermore they will be administered 80 g placebo (carbo fuel in a shaker with water) daily during a 6-week intervention. Participants will be instructed to provide documentation of both the inhalation and the shaker intake via video.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal muscle hypertrophy
Time Frame: Through study completion, an average on 7 weeks
Muscle hypertrophy measured using Dual-energy X-ray Absorptiometry (DXA).
Through study completion, an average on 7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps strength
Time Frame: Through study completion, an average on 7 weeks
Maksimal torque (Nm) achieved during isometric contraction
Through study completion, an average on 7 weeks
Power output during sprint testing
Time Frame: Through study completion, an average on 7 weeks
Power output measured in Watts during a sprint on a bike ergometer
Through study completion, an average on 7 weeks
Power output during time trial
Time Frame: Through study completion, an average on 7 weeks
Mean power output measured in Watts during a time trial on a bike ergometer
Through study completion, an average on 7 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal oxygen uptake
Time Frame: Through study completion, an average on 7 weeks
Maximal oxygen uptake measured during an incremental test to exhaustion on a bike ergometer.
Through study completion, an average on 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2024

Primary Completion (Estimated)

December 18, 2026

Study Completion (Estimated)

December 18, 2026

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SALM_chron

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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